Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder

NCT ID: NCT06790576

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-01

Brief Summary

The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits.

Step 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network.

Step 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants.

Step 3: Following randomization, the study will administer a pre-iTBS assessment.

Step 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group.

Step 5: The study will administer a post-iTBS assessment.

Conditions

Stimulant Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

Participants assigned to closed-loop-peak

Group Type: EXPERIMENTAL

closed-loop-peak

Intervention Type: OTHER

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-peak (each pulse synchronized to person's peak of theta waveform)

Group 2

Participants assigned to open-loop

Group Type: EXPERIMENTAL

Open-loop

Intervention Type: OTHER

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: open-loop (TMS pulse delivered without regard to EEG)

Group 3

Participants assigned to closed-loop-trough

Group Type: EXPERIMENTAL

closed-loop-trough

Intervention Type: OTHER

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-trough (each pulse synchronized to trough of theta waveform)

Interventions

closed-loop-peak

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-peak (each pulse synchronized to person's peak of theta waveform)

Intervention Type: OTHER

Open-loop

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: open-loop (TMS pulse delivered without regard to EEG)

Intervention Type: OTHER

closed-loop-trough

With single pulse TMS stimulation at F3 based on 10-20 EEG system, TMS evoked potentials (TEPs) will be collected under three TMS synchronization conditions: closed-loop-trough (each pulse synchronized to trough of theta waveform)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Ability to provide consent and comply with all study procedures.
• Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).
• At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).
• Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).
• Confident level of English language proficiency.

Exclusion Criteria

• Any organic brain disorder (e.g. TBI, stroke).
• Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.
• TMS contraindication (history of seizures, metallic cranial plates/screws or implanted device).
• MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).
• Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).
• Presence of a condition that would render study measures impossible to administer or interpret.
• Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.
• Greater than 9 months abstinence from substance use (does not apply to healthy control participants).
• Pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin Lim

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melnie Martie

Role: CONTACT

stima011@umn.edu

612-301-2449

Facility Contacts

Melanie Martie

Role: primary

stima011@umn.edu

612-301-2449

Other Identifiers

PSYCH-2024-32713

Identifier Type: -

Identifier Source: org_study_id